Air sample tracking system and method

ABSTRACT

A system for tracking one or more subjects for collecting airborne contaminants. The system includes one or more subjects configured to collect air contaminants. Each of the one or more subjects includes an identification tag encoded with identification information identifying the each subject. The system further includes an identification reader configured to decode the identification information encoded within the identification tag of a scanned one of the one or more identification tags. A computer receives and stores the decoded identification information in a record in a database. The computer may also receive and stored an identification code for a user who scanned the scanned identification tag in the record in the database. Additional records in the database are created each time the identification tag of one of the one or more subjects is scanned. The one or more subjects are thereby tracked as they collect airborne contaminants and are incubated.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/552,264, entitled “Air Sample Tracking System and Method” and filedOct. 27, 2011, the contents of which application are incorporated hereinby reference.

FIELD OF INVENTION

The present invention relates to devices and methods for monitoringairborne contaminants. In particular, the present invention relates todevices and methods for logging data relating to contaminant-collectionsubjects, e.g., agar plates, as they collect airborne contaminants, areincubated, and are subject to air sampling.

BACKGROUND OF THE INVENTION

Clean rooms found in manufacturing, research, and other facilities aretypically classified into two broad categories based on the static airpressure inside the rooms relative to atmospheric pressure and/or basedon the air pressure in spaces adjacent the clean rooms. A positive airpressure room is maintained at an absolute air pressure greater thanatmospheric pressure, greater than the air pressure in spaces adjacentthe clean room, or both. The positive air pressure in such rooms isprovided by pumping filtered and/or conditioned air into the rooms andcontrolling the flow of air out of the rooms. The adjacent spaces, whichmay be manufacturing facilities or offices, are typically maintained ator close to atmospheric pressure by heating, ventilation, and airconditioning (HVAC) systems, or by providing an opening to theenvironment that allows the adjacent spaces to equilibrate withatmospheric pressure. Thus, air flowing from the positive pressure cleanroom will flow toward the lower pressure in adjacent rooms or to theatmosphere.

When a positive air pressure clean room is breached, air flowing toadjacent spaces or the atmosphere is generally not a problem as long asairborne contaminants present in the clean room do not pose a potentialadverse health effect to people in the adjacent spaces. Typically, theair inside clean rooms in which electronics, aerospace hardware, opticalsystems, military equipment, and defense-related research aremanufactured or conducted may not contain airborne gases, vapors, andparticulate matter at concentrations that present a safety or healthconcern to human health or the environment. However, that is not alwaysthe case, as other operations within those industries may generatecontaminants that are above acceptable levels and, therefore, must beprevented from escaping the clean room without treatment.

A negative air pressure room is maintained at an absolute air pressurethat is either less than atmospheric pressure, less than the airpressure in spaces adjacent the clean room, or both. The negativepressure is maintained by pumping air out of the room at a rate fasterthan that at which filtered and/or conditioned air is pumped into theroom. Negative pressure rooms are often used when there is a concernthat contaminants in the air in the room may pose a potential healththreat to human health in adjacent spaces or the environment.

Notwithstanding the human health and environmental implications, certaintypes of manufacturing and research operations must be conducted withina positive air pressure clean room to satisfy regulatory requirementsand industry-adopted good manufacturing and laboratory quality controlstandards. For example, state and federal regulations, including thosepromulgated by the National Institute for Occupational Safety and Health(NIOSH), may necessitate the use of positive or negative pressure cleanrooms.

In particular, the U.S. Food & Drug Administration (FDA) requires thatpharmaceutical production be done within the confines of clean roomsthat provide for the validation and certification that manufacturedbatches of pharmaceutical products are being produced in a sanitaryenvironment.

Positive and negative air pressure clean rooms have been used for manyyears. U.S. Pat. No. 4,604,111, for example, discloses a negativepressure apparatus and method for protecting the environment andpopulations from airborne asbestos and other particulate contaminationinside a building, which includes an enclosure having a blower to pullair into a filtration unit inside the enclosure and dispel the filteredair to the atmosphere. U.S. Pat. No. 5,645,480 discloses the generalfeatures of a clean room.

Various FDA regulations and standards also specify requirements for airsampling and/or air monitoring equipment to be used inside clean roomsto verify or validate the cleanliness of the facility during certaindrug manufacturing activities. The regulations also provide forelectronic data recording, accuracy, precision, and record-keepingrelating to monitoring the air quality within clean rooms. Similarrequirements are imposed on other industries, such as the biotechnologyindustry.

U.S. Pat. No. 6,514,721 describes an air sampling device and method forcollecting airborne pathogens and psychrometric data from a room or fromremote air samples where the sample volume is electronically controlledby closely monitoring fan speed. That patent illustrates a device thatdraws room air into a sampling device using a pump, which causespathogen-containing particulates in the air to impact a growth/inhibitormedia (a solid, liquid, gel, or mixture thereof) stored in a dish thatis positioned within the sampling device. The patent states thatprevious sampling devices could not achieve a constant volumetric airflow of better than +/−30% relative to a nominal or set-point flow rate,which caused a large variability in calculated concentrations ofpathogens.

As U.S. Pat. No. 6,514,721 patent suggests, one of the keys tosuccessfully monitoring the air quality within a clean room is to ensurethat the air flow rate through the air sampling/monitoring devices isvery accurately determined during the time when a volume of air iscollected. That fact is also appreciated in U.S. Pat. No. 4,091,674,which discloses an electronically timed, positive displacement airsampling pump for use with a wide variety of air sample collectingdevices and in a wide range of environmental conditions. The disclosedinvention is said to provide accurate average flow rate, independentlymetered total volume, operating time register, and audible “rate fault”alarm. In that patent, accuracy is achieved by using a timing circuitcoupled with a mechanical bellows.

U.S. Pat. No. 6,216,548 illustrates a control system flow chart for anair sampling device for use in a controlled environment. In particular,the patent discloses a controller logic that involves turning on a pump,checking pressure, monitoring sampling time, drawing air into thesampler, shutting off the pump, and checking for leaks in the lines. Thepatent also teaches using a purge system for purging the lines andassociated air particulate sampler using a purge gas such as nitrogengas. In that patent, air sampling only occurs at one location (e.g., aprocessing chamber for semiconductor devices).

SUMMARY OF THE INVENTION

In accordance with an aspect of the present invention there is provideda system for tracking one or more subjects. The system includes one ormore subjects configured to collect air contaminants. Each of the one ormore subjects includes an identification tag encoded with identificationinformation identifying the each subject and other information regardingthe each subject. The system further includes an identification readerconfigured to decode the identification information encoded within theidentification tag of a scanned one of the one or more identificationtags. A computer receives and stores the decoded identificationinformation from the identification reader in a record in a database.The barcode scanner may be further configured to transmit locationinformation identifying the location of the scanned one of the one ormore identification tags. The location information is logged by thecomputer with the decoded identification information.

In accordance with another aspect of the present invention, there isprovided a system for sampling air at a plurality of locations in acontrolled environment. The system includes one or more air samplingdevices, a vacuum source, a controller connected to the vacuum source,one or more subjects configured to collect air contaminants in thecontrolled environment, an identification reader, and a computerconfigured to receive data from the identification reader. The one ormore air sampling devices are disposed in a controlled environment, theone or more air sampling devices each comprising a first identificationreader. The controller is configured to be in separate air flowcommunication with the one or more air sampling devices via one or morerespective vacuum air tubes. The controller includes a manifoldconfigured to separately control an actual rate of air flow from the oneor more air sampling devices to the vacuum source via each of the one ormore respective vacuum air tubes to selectively direct air flow fromeach of the one or more respective vacuum air tubes to the vacuumsource. The one or more subjects are configured to collect aircontaminants in the controlled environment. Each of the one or moresubjects includes an identification tag encoded with identificationinformation identifying the each subject. The identification reader isconfigured to decode the identification information encoded within theidentification tag of a scanned one of the one or more identificationtags and to transmit such decoded information to the computer. Thecomputer receives and stores the decoded identification information in arecord in a database.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purpose of illustration, there are shown in the drawings certainembodiments of the present invention. In the drawings, like numeralsindicate like elements throughout. It should be understood that theinvention is not limited to the precise arrangements, dimensions, andinstruments shown. In the drawings:

FIG. 1 is a schematic diagram of an exemplary facility having a cleanroom therein, in accordance with an exemplary embodiment of the presentinvention;

FIG. 2 is a schematic diagram of a tracking/logging and airsampling/monitoring system for use in the clean room of FIG. 1, inaccordance with an exemplary embodiment of the present invention;

FIG. 3A is front planar view of an inline flow control module which maybe used in the system of FIG. 2, in accordance with an exemplaryembodiment of the present invention;

FIG. 3B is a side cross-sectional view of the inline flow control moduleof FIG. 3A, in accordance with an exemplary embodiment of the presentinvention;

FIG. 4A is a front planar view of a wall panel disconnect which may beused in the system of FIG. 2, in accordance with an exemplary embodimentof the present invention;

FIG. 4B is a side cross-sectional view of the wall panel disconnect ofFIG. 4A, in accordance with an exemplary embodiment of the presentinvention;

FIG. 5 illustrates an exemplary subject for collecting airbornecontaminants, the subject including a barcode encoded with informationregarding the subject, in accordance with an exemplary embodiment of thepresent invention;

FIG. 6 illustrates an exemplary air sampling method, in accordance withan exemplary embodiment of the present invention;

FIG. 7 illustrates an exemplary incubation method, in accordance with anexemplary embodiment of the present invention;

FIG. 8 illustrates an exemplary method of tracking and logginginformation regarding one or more contaminant-collection subjects, inaccordance with an exemplary embodiment of the present invention;

FIG. 9 illustrates an exemplary table stored in a database within thesystem of FIG. 2, the table logging information regarding one or morecontaminant-collection subjects, in accordance with an exemplaryembodiment of the present invention; and

FIG. 10 illustrates an exemplary alternative embodiment of thetracking/logging and air sampling/monitoring system of FIG. 1, inaccordance with an exemplary embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

None of the conventional devices described above provide the degree ofcontrol, monitoring, reporting, modularity, and remote operationrequired in the modern clean room. For example, none of the conventionaldevices and air sampling methods described above utilizes multiple airsampling devices with inline flow switches at each air sampling deviceto separately and simultaneously measure the air flow realized at eachindividual air sampling device. Additionally, none of the conventionaldevices and air sampling methods described above provide the ability tosimultaneously monitor and control a variable number of air samplingdevices placed at different locations in a clean room from a single,central location that is remote from the air sampling devices. Finally,none of the conventional devices provide for electronic tracking andlogging of data relating to subjects (e.g., agar plates) while they arecollecting contaminants in the environment of a clean room or while theyare under incubation or air sampling. Accordingly, there is also a needfor an air sampling system and method that allows a user to separatelyand simultaneously track and log data regarding a plurality ofcontaminant-collection subjects while they are collecting contaminantsin the environment of a clean room or while they incubated or subject toair sampling.

Several exemplary embodiments of the invention are described forillustrative purposes, it being understood that the invention may beembodied in other forms not specifically shown in the drawings.

Turning first to FIG. 1, shown therein is a schematic of an exemplaryfacility 100 having one or more clean rooms 102 therein, in accordancewith an exemplary embodiment of the present invention. The clean room102 is surrounded by an adjacent space 104 and the outdoor atmosphere106. The adjacent space 104 may be one or more rooms within the samefacility 100 in which the clean room 102 is located and that adjoin theclean room 102, such as, for example, a separate manufacturing room,another clean room, a finish and fill room, a research laboratory,offices, etc. The clean room 102 and adjacent space 104 are separated bya divider, such as a wall 105.

The clean room 102 in the exemplary facility 100 is capable of beingmaintained at an air pressure P₁ that is less than or greater than theair pressure P₂ of the adjacent space 104 and atmospheric air pressureP_(ATM) of the outdoor atmosphere 106. That is accomplished by an HVACsystem (not shown) that causes conditioned and filtered air to be pumpedinto the clean room 102 at a controlled flow rate Q_(IN) as depicted inFIG. 1. Air inside the clean room 102 that is pumped out of or otherwiseflows out of the clean room 102 is represented by Q_(OUT). When thedifference between Q_(IN) and Q_(OUT) (i.e., Q_(IN)−Q_(OUT)) is greaterthan zero, a positive pressure will be maintained in the clean room 102.And, when the difference between Q_(IN) and Q_(OUT) is less than zero, anegative pressure will be maintained in the clean room 102.

Turning now to FIG. 2, shown therein is a schematic diagram of atracking/logging and air sampling/monitoring system 200, in accordancewith an exemplary embodiment of the present invention. The system 200 isconfigured for use in tracking and logging data regarding a plurality ofsubjects and air sampling and incubation processes applied to theplurality of subjects. During air sampling, air from the clean room 102is drawn over the subjects of the system 200 to collect contaminantspresent in the air of the clean room 102.

The system 200 includes a controller 210 (front view shown), a vacuumpump 220, an optional purge pump (not illustrated), an inline flowcontrol base station 230, and a personal computer (PC) or System Controland Data Acquisition (SCADA) system 240, all of which may be co-locatedtogether in the adjacent space 104, adjacent to or remote from (i.e.,not directly adjacent to) the clean room 102. An example of a controllersuitable for use as the controller 210 is any of the SMA DDCMulti-Location Control Centers made by Veltek Associates, Inc., Malvern,Pa.

The system 200 further includes a plurality of inline flow controlmodules 250 a, 250 b, 250 c, and 250 d and a plurality of air samplingdevices 260 a, 260 b, 260 c, and 260 d, all of which may be co-locatedtogether in the clean room 102. In the exemplary embodiment of thesystem 200 illustrated in FIG. 2 and described herein, the system 200comprises four inline flow control modules 250 a through 250 drespectively connected to four air sampling devices 260 a through 260 d.It is to be understood that the number of inline flow control modules250 a through 250 d and air sampling devices 260 a through 260 d is notlimited by the system 200 to any particular quantity of inline flowcontrol modules 250 or air sampling devices 260. That is, the system 200is linearly scalable to substantially any number, n, of inline flowcontrol modules 250 a through 250 n and any number, n, of air samplingdevices 260 a through 260 n, wherein n is preferably 10. The airsampling devices 260 a through 260 d may be any known air samplingdevice for collecting a volume of air. Preferably, the system 200comprises the same number of air sampling devices 260 a through 260 asinline flow control modules 250 a through 250 n. It is contemplated,however, that the system 200 may include more air sampling devices 260than inline flow control modules 250 so that one or more of the inlineflow control modules 250 is coupled to more than one air sampling device260. An example of an air sampling device suitable for use as the airsampling devices 260 is described in U.S. application Ser. No.13/088,641 (“the '641 Application”), entitled “System and Method for AirSampling in Controlled Environments,” filed Apr. 18, 2011, and publishedas U.S. Pat. App. Pub. No. 2011/0205073, the contents of which areincorporated herein by reference.

The system 200 further includes subjects 265 a, 265 b, 265 c, and 265 d,which are disposed in respective air sampling devices 260 a, 260 b, 260c, and 260 d, at various sites within the clean room 102. The airsampling devices 260 a through 260 d are positioned to collect airbornecontaminants in the clean room 102 using the subjects 265 a through 265d. Specifically, the air sampling devices 260 a through 260 d are usedto collect the air surrounding respective subjects 265 a through 265 d,i.e., to draw air over the subjects 265 a through 265 d during airsampling, so that contaminants in the air of the clean room 102 at sitesof interest are collected by the subjects 265 a through 265 d. Aftersampling air for a desired length of time, the subjects 265 a through265 d are incubated if the expected airborne contaminants are bacteria,viruses, or fungi.

The terms “collecting,” “sampling,” “monitoring,” and the like are notused to refer just to whole air sampling devices, but also to refer todevices that process the flow of fluid in order to separate certaingases, vapors, and particulate matter in the fluid for subsequentanalysis and quantification. The terms “air” and “fluid” are usedinterchangeably to refer to gases, vapors, and particulates. Thus, “airsampler” does not mean that only air is being collected and/ormonitored.

As shown, a separate inline flow control module 250 a through 250 d isassociated with each air sampling device 260 a through 260 d. Each airsampling device 260 a, 260 b, 260 c, and 260 d is connected to itsrespective inline flow control module 250 a, 250 b, 250 c, and 250 d bya respective atrium air flow line 255 a, 255 b, 255 c, and 255 d, andeach inline flow control module 250 a, 250 b, 250 c, and 250 d isconnected to the controller 210 by a respective vacuum air line 215 a,215 b, 215 c, and 215 d, each of which may be ¼-inch (0.6-cm) (insidediameter) vacuum tubing on the clean room 102 side of the system 200 and⅜-inch (1.0-cm) (inside diameter) vacuum tubing on the adjacent space104 side of the system 200. Other sized tubing may also be used.

The controller 210 includes four modular ports, such as the modularports described and illustrated in the '641 Application. Each of suchports is connected a respective one of the vacuum air lines 215 athrough 215 d. Via these ports, the controller 210 is configured to drawin air from the air sampling devices 260 a through 260 d and through theatrium air flow lines 255 a through 255 d and the vacuum air lines 215 athrough 215 d to provide for the air sampling performed by the airsampling devices 260 a through 260 d.

The vacuum air lines 215 a and 215 b are connected across the wall 105via a wall-mounted quick disconnect outlet 112A, and the vacuum airlines 215 c and 215 d are connected across the wall 105 via awall-mounted quick disconnect outlet 112B. The outlets 112A and 112B arelocated on the wall 105 in between the clean room 102 and the adjacentspace 104.

The controller 210 connects the inline flow control modules 250 athrough 250 d to the vacuum pump 220 via a vacuum air line 225. Withinthe controller 210 is a manifold (not shown) that ties all of theindividual vacuum air lines 215 together and connects them to the vacuumside of the vacuum pump 220 via the vacuum air line 225. The controller210 includes individual solenoids (not shown) which are associated withthe vacuum air lines 215 and are used to turn on the air flow to eachinline flow control module 250 a through 250 d and their respective airsampling devices 260 a through 260 d so that any combination of the airsampling devices 260 a through 260 d can be employed simultaneously toperform sampling cycles at various locations throughout the clean room102. In one exemplary embodiment, the controller 210 is configured sothat each atrium air flow line 255 a through 255 d and vacuum air line215 a through 215 d carries 1 CFM (28.3 liters/min) of air, which is thedesired air flow rate needed to conduct a proper sampling cycle at theair sampling devices 260 a through 260 d. In another exemplaryembodiment, the controller 210 is configured to allow for the air flowrates to be individually set, as described below.

The controller 210 communicates with the inline flow control modules 250a through 250 d by way of the inline flow control base station 230 toreceive data and commands from the inline flow control modules 250 athrough 250 d and to provide data to the inline flow control modules 250a through 250 d. The controller 210 includes four communication ports,each of which is connected to the inline flow control base station 230via a respective electrical connection 212 a, 212 b, 212 c, and 212 d.The inline flow control base station 230 is connected to each of theinline flow control modules 250 a through 250 d via a respectiveelectrical connection 232 a, 232 b, 232 c, and 232 d. The electricalconnections 232 a and 232 b are connected across the wall 105 via aconnector 114A, and the electrical connections 232 c and 232 d areconnected across the wall 105 via a connector 114B. The controller 210may contain any of the functionality of any of the controllers describedin the '641 Application to control the vacuum pump 220 and communicatewith the inline flow control modules 250 a through 250 d.

The various inline flow control modules 250 a through 250 d are shownconnected in a parallel manner to the inline flow control base station230 via the electrical connections 232 a through 232 d, and base station230 is shown connected in a parallel manner to the controller 210 viathe electrical connections 212 a through 212 d. It is to be understood,however, that the controller 210, the inline flow control base station230, and the inline flow control modules 250 a through 250 d can beconnected in any suitable manner. For example, in an exemplaryalternative embodiment, the inline flow control modules 250 a through250 d have network addresses, and the controller 210 communicates withthe different inline flow control modules 250 a through 250 d by use ofthose network addresses via a common connection (e.g. a singleelectrical connection 212, such as may be used in an Ethernet network orwireless local area network (LAN)).

The exemplary embodiment of the system 200 illustrated in FIG. 2illustrates four electrical connections 212 a through 212 d and fourelectrical connections 232 a through 232 d, each of which corresponds toa respective one of the inline flow control modules 250 a through 250 dand the air sampling devices 260 a through 260 d. It is to be understoodthat the number of electrical connections 212 a through 212 d andelectrical connections 232 a through 232 d is not limited by the system200 to any particular quantity of electrical connections. That is, thesystem 200 is linearly scalable to substantially any number, n, ofelectrical connections 212 a though 212 n and electrical connections 232a through 232 n. Furthermore, although the controller 210, the inlineflow control base station 230, and the inline flow control modules 250 athrough 250 d are shown in wired communication with one another, it isto be appreciated that these components of the system 200 maycommunicate wirelessly, in an alternative exemplary embodiment of thesystem 200.

The base station 230 includes internal interfaces (not illustrated) forinterfacing with the controller 210, and the controller 210 includesinternal interfaces (not illustrated) for interfacing with the basestation 230. The base station 230 forwards data (e.g., flow rates, alarmconditions, etc.) and commands (e.g., to start and/or stop air flow)received from the inline flow control modules 250 a through 250 overrespective electrical connections 232 a through 232 d to the controller210 via the respective electrical connections 212 a through 212 d. Thecontroller 210 receives such data and commands. The base station 230also forwards data and commands received from the controller 210 via theelectrical connections 212 a through 212 d to the inline flow controlmodules 250 a through 250 over respective electrical connections 232 athrough 232 d. Various examples of data and commands transmitted by theinline flow control modules 250 a through 250 and the base station 210are described below.

The PC or SCADA system 240 is also connected to the base station 230 viaan electrical connection 254 and also includes an internal interface forcommunicating with the base station 230, and, likewise, the base station230 includes an internal interface for interfacing with the PC or SCADAsystem 240. The base station 230 may forward all data and commandsprovided by the inline flow control modules 250 a through 250 and thecontroller 210 to the PC or SCADA system 240 for tracking and monitoringthe system 200 in real time and logging the data and commands in adatabase 290 maintained by the PC or SCADA system 240. Although thesystem 200 is described and illustrated herein as including the database290, it is to be understood that the system 200 is not so limited. Inother exemplary embodiments, the element 290 is a spreadsheet, a flattext file, or other data structure stored in a computer-readable medium.

The inline flow control modules 250 a through 250 d are configured toindependently monitor various data during operation, e.g., during airsampling. Such data include any flow rates sensed by the respectiveinline flow control modules 250 a through 250 d, alarm signals generatedby the respective inline flow control modules 250 a through 250 d, etc.For example, the inline flow control modules 250 a through 250 d monitorand display the actual flow rate that is realized at their respectiveair sampling devices 260 a through 260 d. If the flow rate in arespective vacuum air line 215 a through 215 d is off by +/−0.5% (i.e.,not within the range of 0.95-1.05 CFM or 26.9-29.7 liters/min), then thecorresponding inline flow control module 250 a through 250 d generatesan alarm signal.

In an exemplary embodiment, each inline flow control module 250 athrough 250 d includes an 8-second delay before the alarm signal isgenerated. That delay accounts for fluctuations that may occur duringinitial start-up of the system 200. A typical sampling cycle may lastbetween 10 minutes and 3 hours.

An additional aspect of this exemplary embodiment provides that the basestation 230 communicates any data and alarm signals received from theinline flow control modules 250 a through 250 d to the other inline flowcontrol modules 250 a through 250 d, so that they may activate theirrespective visual alert indicators and audible alarms, and/or to thecontroller 210. The flow rates are communicated to the base station 210,where they are also monitored and controlled independently by the basestation 210.

During operation, the controller 210 also monitors data relating to airsampling. For example, the controller 210 monitors flow rates throughthe ports of the controller 210, whether the individual ports of thecontroller 210 are powered up, and whether the ports are in an airsampling mode and/or are experiencing an air flow error during an airsampling cycle. The controller 210 may transmit any of such data to thebase station 230 for sending to the inline flow control modules 250 athrough 250 d. The detection of air flow rates performed by the inlineflow control modules 250 a through 250 d is independent of the flow ratedetection performed by the controller 210 so that the flow rates aresimultaneously monitored at two locations for each air sampling device260 a through 260 d during a sampling cycle, thereby adding anadditional measure of safety through redundancy.

As depicted in FIG. 2, the system 200 further includes a touchpanel 270,which is connected to the inline flow control base station 230 via anelectrical connection 275. The electrical connection 275 may be a wiredor wireless communication. The touchpanel 270 may be co-located with thecontroller 210, or otherwise outside the clean room 102, or it may beco-located with the inline flow control modules 250 a through 250 d andthe air sampling devices 260 a through 260 d in the clean room 102, asshown in FIG. 2. The touchpanel 270 includes an interface forcommunicating with the base station 230 for receiving data from the basestation 230 and providing commands to the base station 230 for relayingto their proper destinations. It is to be understood that the touchpanel270 may be configured to receive any data and commands provided to thebase station 230 described herein.

For example, when the base station 230 and the touchpanel 270communicate, the touchpanel 270 may receive data from the controller 210collected during an air sampling period. As described above, such datamay indicate whether the individual ports of the controller 210 arepowered up, are in an air sampling mode, and/or experience an air flowerror during an air sampling cycle. In that way, the touchpanel 270 candetect the state of activity of each of the individual ports of thecontroller 210, thereby allowing a user to determine where in thefacility 100 air sampling is being conducted (i.e., which air samplingdevices 260 a through 260 d are presently being operated, the timeassociated with a sampling cycle, etc.) and at which air samplingdevices 260 a through 260 d any errors occur. Such data may furtherindicate the flow rates sensed in the inline flow control modules 250 athrough 250 d, alarm conditions in the inline flow control modules 250 athrough 250 d, etc. Thus, the touchpanel 270 may be used to displaydata, e.g., data collected during an air sampling period or other datadescribed below, in real time regarding components of the system 200.

The touchpanel 270 may also be configured to provide commands tocomponents of the system 200, such as the inline flow control modules250 a through 250 d and the controller 210. For example, the touchpanel270 also be used to remotely start and stop sampling at various airsampling devices 260 a through 260 d within the facility 100, therebyeliminating the need for the user to access the controller 210 or theinline flow control modules 250 a through 250 d directly to performthese functions. Thus, in an exemplary embodiment, the touchpanel 270includes various input means, such as a touch screen, switches, or amini-keyboard, that receive input from a user to signal to thecontroller 210 which air sampling devices 260 a through 260 d tooperate. The touchpanel 270 communicates such commands to the controller210 via the base station 230, thereby eliminating the need for the userto leave the location (room) of the touchpanel 270 to operate thecontroller 210 or the inline flow control modules 250 a through 250 d.

In an exemplary embodiment, the system 200 further includes a portablebarcode scanner 280 for collecting data regarding the subjects 265 athrough 265 d, a user operating the barcode scanner 280, and therooms/sites in which the subjects 265 a through 265 d are located duringair sampling and incubation periods of the subjects 265 a through 265 d.The barcode scanner 280 transmits such data wirelessly to the basestation 230 by a wireless channel 285. The base station 230 may forwarddata received from the barcode scanner 280 to the touchpanel 270 forreal-time display thereon. For example, the data may includeidentification data, location data, times and dates of scans, etc. forthe subjects 265 a through 265 d, etc. The touchpanel 270 receives suchdata on the subjects 265 a through 265 d scanned by the barcode scanner280 via the controller 210, in real time, and displays it. Thetouchpanel 270 may be configured to receive a user selection to viewsuch data for only a selected one of the subjects 265 a through 265 d.In an exemplary embodiment, the barcode scanner 280 comprises a computerdisplay which prompts the user 500 to scan the subjects 265 a through265 d, the user 500's barcode 510, and the room/sites barcodes.

In another exemplary embodiment, the touchpanel 270 includes, or isconnected to, a barcode scanner, which is configured to havefunctionality similar to that of the portable barcode scanner 280 forcollecting data regarding the subjects 265 a through 265 d, the user ofthe touchpanel 270, and the rooms/sites in which the subjects 265 athrough 265 d are located during air sampling and incubation. Afterscanning a barcode using the barcode scanner connected to the touchpanel270, the touchpanel 270 transmits the scanned data to the base station230 by the electrical connection 275.

In an exemplary embodiment, PC or SCADA system 240 monitors conditionsin the clean room 102 and may monitor conditions in other rooms, e.g.,other clean rooms 102 or rooms 104. The PC or SCADA system 240 includessoftware that includes a graphical representation of the differentcomponents of the system 200, e.g., images representing the front of thecontroller 210, the inline flow control modules 250 a through 250 d (orthe inline flow control modules 250 a and/or the wall panel disconnects250 a′, described below), the touchpanel 270, and the portable barcodescanner 280. The PC or SCADA system 240 may include software to rendersuch representations, receive real-time data from the base station 230for these components, and display the real-time data in therepresentations to create a real-time “virtual” reproduction of thesystem 200. The PC or SCADA system 240 may also be configured to controlthe system 200, similarly to the touchpanel 270.

The PC or SCADA system 240 may also be configured to collect and storedata regarding the operation of the components of the system 200 andcommands provided by components of the system 200. Data recorded by thePC or SCADA system 240 may include data obtained during an air samplingperiod (the period of time over which the subjects 265 a through 265 dcollect airborne contaminants from a clean room, such as the clean room102) and data obtained during an incubation period (the period of timeover which the contaminants in the subjects 265 a through 265 d, if theyare viruses, bacteria, or fungi, are incubated). Such data may includedata scanned by a barcode scanner, data inputted by a user, and datamonitored by the inline flow control modules 250 a through 250 d and thecontroller 210. The PC or SCADA system 240 receives the data andcommands for storage from the base station 230 and stores them in thedatabase 290 or other memory.

Data obtained during an air sampling period may include any of thefollowing inputted or scanned data: (1) identification data of thesubjects 265 a through 265 d obtained by a barcode scanner; (2) locationdata of the subjects 265 a through 265 d obtained by or generated by thebarcode scanner; (3) the date and time such location data was obtained,i.e., when the scan was performed; (4) identification data of the personoperating the barcode scanner; and (5) the date and, optionally, time(obtained by the barcode scanner) the subjects 265 a through 265 dexpire. Data obtained during the air sampling period may also includeany of the following monitored data: (1) the flow rate at eachindividual air sampling device 260 a through 260 d; (2) the dates andtimes of the measured flow rates; (3) flow alerts/alarms generated atthe inline flow control modules 250 a through 250 d; (4) indications ofwhether the individual ports of the controller 210 are powered up; (5)indications of whether the individual ports of the controller 210 are inan air sampling mode; (6) air flow errors detected by the controller210; and (7) flow rates detected by the controller 210. It is to beunderstood that the date and time data for the scan may be automaticallygenerated by an internal electronic clock within the barcode scanner280, the base station 230, the touchpanel 270, or the PC or SCADA system240. Alternatively, such date and time data may be manually entered bythe user using the barcode scanner.

Data obtained during the incubation period include any of the following:(1) identification data of the subjects 265 a through 265 d obtained bya barcode scanner; (2) location data of the subjects 265 a through 265 dobtained by or generated by the barcode scanner; (3) the date and timesuch location data was obtained, i.e., when the scan was performed; (4)identification data of the person operating the barcode scanner; (5) andremarks entered by a user. It is to be understood that the date and timedata for the scan may be automatically generated by an internalelectronic clock within the barcode scanner, the base station 230, thetouchpanel 270, or the PC or SCADA system 240. Alternatively, such dateand time data may be manually entered by the user using the barcodescanner.

The base station 230 is the gateway of data and commands received fromthe various components of the system 200 and forwarded to the PC orSCADA system 240, which may log the data and commands in the database290 for later retrieval and/or which may provide for real-timemonitoring and display by the PC or SCADA system 240. In an additionalexemplary embodiment, the touchpanel 270 may access the historical data,such as past identification data, location data, dates, times, etc.,logged by the PC or SCADA system 240 in the database 290. Using thetouchpanel 270, an operator may request information about a selectedsubject 265 a through 265 d. The touchpanel 270 receives such selectionand forwards it to the controller 210. The controller 210 forwards theselection to the PC or SCADA system 240, which responds with the desiredhistorical data. For example, using the touchpanel 270, the operatorselects one of the subjects 265 a through 265 d. The controller 210responds with identification data, historical location data, historicaltimes and dates of scans, etc. for the selected subject 265 a through265 d. The touchpanel 270 displays such historical data.

To facilitate the real-time monitoring of the system 200 and the loggingof data regarding the system 200, the PC or SCADA system 240 includesany suitable computing processor or processing platform that is capableof performing the functions and operations of the exemplary embodimentsof the PC or SCADA system 240 described herein, e.g., real-timemonitoring of data and commands in the system 200, tracking and loggingof data and commands of the system 200 in the database 290, andrecalling of historical data stored in the database 290. The PC or SCADAsystem 240 includes a computer-readable medium comprising software codestored thereon that, when executed by the PC or SCADA system 240, causesthe PC or SCADA system 240 to perform any of the functionality of the PCor SCADA system 240 described herein. Thus, all or parts of thefunctionality of the PC or SCADA system 240 that provide for remotelymonitoring the system 200, storing data and commands in the database290, and retrieving stored (historical) data from the database 290 maybe stored as computer-readable software instructions in acomputer-readable media and retrieved from the computer-readable mediaand executed to perform the functions of the PC or SCADA system 240described herein.

The computing platform for the PC or SCADA system 240 is desirably apersonal computer or server, either in a stand-alone system or as partof a network. It is also contemplated that the PC or SCADA system 240may be a laptop computer, a tablet PC, a Personal Digital Assistant(PDA), a smart phone, etc. The PC or SCADA system 240 desirably includesa display for a user to monitor the status of the various components ofthe system 200 and includes a user input, such as a keyboard, key pad,or touch screen, for the user to input instructions for controlling thesystem 200, selectively monitoring components of the system 200, orrecalling historical data from the database 290. It is to be understoodthat the PC or SCADA system 240 can be connected to any number ofsystems 200 at any number of locations, thereby providing a mechanismfor monitoring and controlling multiple clean rooms 102 from a single,central location. And, the same functionality may be provided via asecure website from which a user can remotely monitor and control anynumber of systems 200 over the Internet from virtually any location,adding yet another degree flexibility and accessibility to the presentinvention.

Referring now to FIGS. 3A and 3B, there are respectively illustrated afront view and a side cross-sectional view of the inline flow controlmodule 250 a, in accordance with an exemplary embodiment of the presentinvention. It is to be understood that any or all of the inline flowcontrol modules 250 b through 250 d in the system 200 may be configuredas the inline flow control module 250 a illustrated in FIGS. 3A and 3Band described below.

The inline flow control module 250 a includes a housing 310 having adigital air flow switch interface 320, a stop switch 330, a start switch340, dual alert/alarm indicators 350 (visual) and 360 (audible), an airflow plug adapter 355, and an air flow switch 380. The inline flowcontrol module 250 a is electrically connected to the base station 230via the electrical connection 232 a and is fluidly connected to thecontroller 210 via the vacuum air line 215 a and to the air samplingdevice 260 a via the atrium air flow line 255 a, which is removablyconnectable to the air flow pug adapter 355.

The digital air flow switch interface 320 is configured for receivingset points for the flow rates in the vacuum air line 215 a and theatrium air flow line 255 a from a user. The digital air flow switchinterface 320 includes a digital LED display 325 and various buttons 322that allow the user to set the desired range of flow rates in the vacuumair line 215 a and the atrium air flow line 255 a. The digital air flowswitch interface 320 communicates these set points to the controller 210to control the air flow through the vacuum air line 215 a and the atriumair flow line 255 a during an air sampling cycle.

The start switch 340 is used to manually activate an air samplingperiod. In response to the start switch 340 being activated, the inlineflow control module 250 a sends a signal to the controller 210 via thebase station 230, which may also forward the signal to the PC or SCADAsystem 240 for logging in the database 290. The controller 210 activatesthe vacuum pump 220 to cause an air flow in the vacuum air line 215 a,the air flow plug adapter 355, and the atrium air flow line 255 a at theflow rate set in the digital air flow switch interface 320.

The stop switch 330 aborts the sampling cycle and turns off the vacuumair flow for the air sampling device 260 a. When the stop switch 330 isactivated, a stop signal is sent to the controller 210 via the inlineflow control base station 230, which may also forward the signal to thePC or SCADA system 240 for logging. In response, the controller 210closes off the vacuum air line 215 a from the vacuum pump 220. The usermay abort the sampling cycle for various reasons, including that analert/alarm has been signaled by the inline flow control module 250 a.

The digital air flow switch 380 is configured for monitoring the airflow rate in the vacuum air line 215 a and the atrium air flow line 255a and for detecting airflow errors (e.g., 1 CFM errors) during asampling cycle. Specifically, the air flow switch 380 measures the airflow rate through the vacuum air line 215 a and compares it to the setflow rate. The digital air flow switch 380 generates a flow alert/alarmwhen the flow measured for the air sampling device 260 a is outsidespecification (e.g., not within the range of 0.95-1.05 CFM or 26.9-29.7liters/min). The alert/alarm indicators 350 and 360 then indicate. Botha visual alert indicator 350, such as an LED, and an audible alarm 360,such as a buzzer, are provided to alert the user when the flow rate isout of specification. The alert and alarm continue until the stop switch330 is activated, or the error conditions are removed, and the flow ratereturns to the desired level (e.g., 1 CFM or 28.3 liters/min).

In accordance with an exemplary embodiment of the inline flow controlmodule 250 a, air flow is only activated and de-activated in the vacuumair line 215 a when the user manually operates the start switch 340 andthe stop switch 330, respectively. That way, the user can verify thatthe air sampling device 260 a connected to the inline flow controlmodule 250 a is properly set up and ready to perform a sampling cycle.However, it should be appreciated that the system can be configured sothat the user can start and stop air flow to other or all of the inlineflow control modules 250 b through 250 d configured as the inline flowcontrol module 250 a in the system 200, either simultaneously or atother times, at any of the inline flow control modules 250 a through 250d, or at either the controller 210, the inline flow control base station230, the PC or SCADA system 240, or the touchpanel 270.

The air flow plug adapter 355 is provided on the front face of thehousing 310 of the inline flow control module 250 a and is adapted toconnect to the atrium air flow line 255 a to connect to the air samplingdevice 260 a. The plug adapter 355 is preferably a quick disconnect sothat the atrium air flow line 255 a can be quickly connected anddisconnected and replaced, if necessary. The inline flow control module250 a can be mounted either internally to the wall 105 or externally onthe face of the wall 105. The electronics of the inline flow controlmodule 250 a may be sealed inside the housing 310 so that the device maybe disinfected like other portions of the clean room 102.

FIG. 3B shows the internals of the inline flow control module 250 a,including the air flow switch 380, which couples the vacuum air line 215a to the plug adapter 355, so that the atrium air flow line 255 a may beeasily connected and disconnected from the vacuum air line 215 a. In anexemplary embodiment, the air flow switch 380 is a digital air flowswitch that may be constructed similarly to the air flow switches withinthe controller 210.

The air flow switch 380 is configured to detect the flow rate coming infrom the atrium air flow line 255 a connected to the plug adapter 355and passing through to the vacuum air line 215 a. The air flow switch380 generates an alarm signal if the detected air flow rate is notwithin the parameters set by the user, e.g., 1 CFM or 28.3 liters/min.If an alarm signal is generated, the alert/alarm indicators 350 and 360are activated and an alarm signal is forwarded to the base station 230.

The electrical connection 232 a is connected to a data port on the airflow switch 380 and to the alert/alarm indicators 350 and 360. Dataregarding the flow rate detected by the air flow switch 380 and alarmconditions generated by the air flow switch 380 are transmitted,optionally with a date and time stamp, to the controller 210 via thebase station 230. In addition, the flow rate coming in from the atriumair flow line 255 a and passing through to the vacuum air line 215 a isalso sensed and monitored by the controller 210 independently from theflow rate detection performed by the air flow switch 380 in the inlineflow control module 250 a so that the flow rate is simultaneouslymonitored at two locations during a sampling cycle. All such data andoptional date and time stamps may be transmitted to the PC or SCADAsystem 240 via the base station 230 for storage.

For example, the air flow switch 380 may identify an error in the flowrate from the air sampling device 260 a due to a break in the vacuum airline 215 a between the controller 210 and the inline flow control module250 a, which is particularly advantageous when the vacuum air line 215 ais within the wall 105 or near noisy equipment such that a break wouldotherwise be difficult to detect. The air flow switch 380 may alsoidentify an error in the flow rate from the air sampling device 260 awhere either the atrium air flow line 255 a or the vacuum air line 215 ais kinked or not properly connected. And, the air flow switch 380 mayidentify if the vacuum pump 220 is not turned on or working properly.When identified, such problems can be corrected without affecting anyother sampling devices 260 b through 260 d.

As also illustrated in FIGS. 3A and 3B, the inline flow control module250 a further includes a barcode scanner 370, which is electricallyconnected to the electrical connection 232 a to communicate with thebase station 230 and the controller 210. As described in further detailbelow, the barcode scanner 370 is configured to collect data regardingthe subject 265 a, such as identification data for the subject 265 a andthe date and time the subject 265 a was scanned by the barcode scanner370, for transmission back to the base station 230. It is to beunderstood that the barcode scanner 370 may include functionality thatis similar to the barcode scanner connected to the touchpanel 270 andthe barcode scanner 280.

Referring now to FIGS. 4A and 4B, there are respectively illustrated afront view and a side cross-sectional view of a wall panel disconnect,generally designated as 250 a′, in accordance with an exemplaryembodiment of the present invention. In an exemplary embodiment of thesystem 200, the wall panel disconnect 250 a′ may replace any of theinline flow control modules 250 a through 250 d as wall paneldisconnects 250 a′ through 250 d′.

The wall panel disconnect 250 a′ includes a panel 410, to which the plugadapter 355 and the barcode scanner 370 are mounted. The plug adapter355 is connected to the vacuum line 215 a, which communicates back tothe controller 210. The barcode scanner 370 is connected to theelectrical connection 232 a, which communicates back to the base station230. Also mounted to the panel 410 of the wall panel disconnect 400 isthe air sampling device 260 a, which is coupled to the plug adapter 355and the vacuum line 215 a by the atrium air flow line 255 a.

The wall panel disconnect 250 a′ is simplified from the inline flowcontrol module 250 a. The wall panel disconnect 250 a′does not includestart and stop switches, flow monitoring, or alarming, as the flowcontrol module 250 a does. Rather, such functionality resides in thecontroller 210, the PC or SCADA system 240, or the touchpanel 270. Forexample, airflow through the atrium air flow line 255 a, the plugadapter 355, and the vacuum line 215 a is monitored by a respective flowcontrol switch in the controller 210. The wall panel disconnect 250 a′does not include a digital air flow switch, such as the air flow switch380 included in the inline flow control module 250 a. As described infurther detail below, the barcode scanner 370 is configured to collectidentification information, such as information identifying the airsampling device 260 a, for transmission back to controller 210 via thebase station 230.

As described above, the inline flow control modules 250 a through 250 dand the wall panel disconnects 250 a′ through 250 d′ each include abarcode scanner 370. The system 200 also includes an optional barcodescanner connected to the touchpanel 270 and/or an optional barcodescanner 280. Any of these barcode scanners may be used to collect datarelating to the subjects 265 a through 265 d during operation of thesystem 200.

FIG. 5 illustrates an exemplary embodiment of the subject 265 a, whichis subjected (exposed) to the environment of the clean room 102 tocollect contaminants in the air of the clean room 102 during an airsampling period and then placed into incubation after a period ofexposure in the clean room 102 if the contaminants are bacteria,viruses, and/or fungi, in accordance with an exemplary embodiment of thepresent invention. The subject 265 a includes a barcode 266 a, whichincludes encoded information about the subject 265 a. Such informationmay include any of the following: (1) an expiration date of the subject265 a; (2) a lot number of the subject 265 a; (3) media and fill of thesubject 265 a (in embodiments in which the subject 265 a is an agarplate); and (4) an identification code (identification data) uniquelyidentifying the subject 265 a compared to other subjects which may besampled by the system 200. In an exemplary embodiment, theidentification code for the subject 265 a comprises a date the barcode266 a was generated and a unique serial number appended thereto. In analternative exemplary embodiment, this date is replaced with the lotnumber.

The user 500 may be associated with a barcode 510, which is worn on anID badge or contained on an ID card. The barcode 510 includes encodedinformation about the user 500. Such information may include anidentification code (identification data) uniquely identifying the user500 compare to all other users. Finally, the room and site within theroom in which the subject 265 a is located may include a barcode (notillustrated), which includes encoded information about the room andsite, such as a unique ID code for the room and a unique ID code for thesite within the room. Although FIG. 5 illustrates the subject 265 aincluding the barcode 266 a and description below is made with referenceto the subject 265 a and the barcode 266 a, it is to be understood thatdescription herein relating to the subject 265 a and the barcode 266 aapplies to the subjects 265 b through 265 d and their barcodes 266 bthrough 266 d. Further, although FIG. 5 illustrates the barcodes 266 aand 510 as one-dimensional barcodes, other embodiments in which they aretwo-dimensional barcodes are contemplated.

During the air sampling period, the user 500 uses a barcode scanner,such as the barcode scanner connected to the touchpanel 270, the barcodescanner 280, or the barcode scanner 370, to scan the barcode 266 a ofthe subject 265 a to retrieve the information encoded within the barcode266 a. The user 500 may also use the barcode scanner to scan the barcode510 to retrieve the information about the user 500 encoded within thebarcode 510 and the barcode(s) identifying the location of the subject265 a (room and site at which the subject 265 a is situated). During theincubation period, the user 500 uses the barcode scanner to scan thebarcode 266 a to retrieve the information encoded within the barcode 266a. The user 500 may also use the barcode scanner to scan the barcode 510to retrieve the information about the user 500 encoded within thebarcode 510 and the barcode(s) identifying the location of the subject265 a (room and site at which the subject 265 a is situated).

The barcode scanner receives the information encoded within the barcodesas optically encoded signals. The barcode scanner converts the opticallyencoded signals to electrical signals encoded with the informationcontained within the barcodes. The barcode scanner decodes theinformation and transmits it to the base station 230. The base station230 forwards the information to the PC or SCADA system 240 for storageand/or real-time tracking, and optionally to the touchpanel 270 forreal-time presentation. In an exemplary embodiment, the informationencoded within the barcode 266 a is stored by the PC or SCADA system 240in association with the user information from the barcode 510. Bylogging when and where the subject 265 a is located, the system 200 isable to electronically track the subject 265 a as it is exposed tocontaminants in an environment.

In an exemplary embodiment, the date and times of the scans may beinputted by the user 500 into the barcode scanner and sent to the PC orSCADA system 240 to provide a time stamp to the scan stored in the PC orSCADA system 240. Alternatively, in another exemplary embodiment, the PCor SCADA system 240 or the barcode scanner may automatically generatethe time stamp. Furthermore, in exemplary embodiments in which thebarcode scanner used is stationary, such as the barcode scanner 370 orthe barcode scanner connected to the touchpanel 270, such barcodescanner may be configured to provide the location data for the room andsite of the scan, thereby obviating the need to scan a barcode forlocation data for the room and site.

Referring now to FIG. 6, there are illustrated exemplary steps of amethod 600 of performing air sampling, in accordance with an exemplaryembodiment of the present invention. The method 600 is described withreference to using the barcode scanner connected to the touchpanel 270,the barcode scanner 280, or the barcode scanner 370 of the inline flowcontrol module 250 a when conducting air sampling using the inline flowcontrol module 250 a. It is to be understood that operation of any ofthe inline flow control modules 250 b through 250 d or the wall paneldisconnects 250 a′ through 250 d′ during air sampling may be similar tothe operation of the inline flow control module 250 a described below.

At the start of the air sampling period, the user 500 uses the barcodescanner to scan the barcode 266 a to retrieve the information encodedwithin the barcode 266 a, Step 602. Optionally, in the Step 602, theuser 500 also uses the barcode scanner to scan the barcode 510 toretrieve the information about the user 500 encoded within the barcode510 and/or to scan barcode(s) located at the air sampling room/sitecontaining location information about the sampling room/site and/or toenter remarks regarding the scan. In a Step 604, all scannedinformation, any entered remarks, and location information regarding thescan site are decoded and transmitted to the base station 230. The basestation 230 forwards this information to the PC or SCADA system 240 forstorage and/or real-time tracking and/or to the touchpanel 270 forreal-time presentation. The PC or SCADA system 240 stores thisinformation in a new record in the database 290.

After scanning the barcode 266 a and the optional user barcode 510 androom/site barcode(s), the subject 265 a is placed into the inline flowcontrol module 250 a by the user 500, Step 606. The user 500 depressesthe start button 340 to start the air sampling cycle. The air samplingdevice 260 a samples air surrounding the subject 265 a, which air flowsto the controller 210 via the vacuum air line 215 a at a flow rate setin the inline flow control module 250 a in the Step 606.

At the conclusion of the air sampling cycle in the Step 606, the user500 re-scans the barcode 266 a and may, optionally, scan the barcode 510and/or the barcode(s) (if present) located at the air sampling room/sitecontaining location information about the air sampling room/site and/ormay enter remarks regarding the scan, Step 608. In a Step 610, allscanned information, any entered remarks, and location informationregarding the air sampling site obtained in the scan in the Step 608 aredecoded and transmitted to the base station 230. The base station 230forwards this information to the PC or SCADA system 240 for storageand/or real-time tracking and/or to the touchpanel 270 for real-timepresentation. The method 600 concludes with the user 500 or anotherperson transporting the subject 265 a to incubation, Step 612.

Referring now to FIG. 7, there are illustrated exemplary steps of amethod 700 of incubating the subject 265 a, in accordance with anexemplary embodiment of the present invention. The method 700 isdescribed with reference to using the barcode scanner connected to thetouchpanel 270, the barcode scanner 280, or the barcode scanner 370 ofthe inline flow control module 250 a when incubating the subject 265 a.

At the start of the incubation period, the user 500 uses the barcodescanner to scan the barcode 266 a to retrieve the information encodedwithin the barcode 266 a, Step 702. Optionally, in the Step 702, theuser 500 also uses the barcode scanner to scan the barcode 510 toretrieve the information about the user 500 encoded within the barcode510 and/or to scan barcode(s) located at the air sampling room/sitecontaining location information about the sampling room/site and/or toenter remarks regarding the scan. In a Step 704, all scannedinformation, any entered remarks, and location information regarding thescan site are decoded and transmitted to the base station 230. The basestation 230 forwards this information to the PC or SCADA system 240 forstorage and/or real-time tracking and/or to the touchpanel 270 forreal-time presentation. The PC or SCADA system 240 stores thisinformation in a new record in the database 290.

After scanning the barcode 266 a and the optional user barcode 510 androom/site barcode(s), the subject 265 a is placed into incubation by theuser 500, Step 706. During the air incubation period, the user 500 mayperiodically re-scan the barcode 266 a, log observations/remarksregarding the subject 265 a, and may, optionally, scan the barcode 510and/or the barcode(s) (if present) located at the incubation room/sitecontaining location information about the incubation room/site, Step708. In a Step 710, all scanned information, any entered remarks, andlocation information regarding the room/site obtained in the Step 708are decoded and transmitted to the base station 230. The base station230 forwards this information to the PC or SCADA system 240 for storageand/or real-time tracking and/or to the touchpanel 270 for real-timepresentation.

At the conclusion of incubation, the user 500 again scans and/or entersinformation in the Step 708. In the Step 710, all scanned information,any entered remarks/observations, and location information regarding theincubation room/site obtained in the final scan in the Step 708 aredecoded and transmitted to the base station 230. The base station 230forwards this information to the PC or SCADA system 240 for storageand/or real-time tracking and/or to the touchpanel 270 for real-timepresentation. The method 700 concludes with the PC or SCADA system 240transferring the records in the database 290 for the subject 265 aelectronically to the cognizant department, Step 712.

In an exemplary embodiment, the PC or SCADA system 240 is configured toanalyze the records in the database 290 for a room/site to determine anytrends in air contaminants. The PC or SCADA system 240 determines if anumber of colonies in the subject 265 a meets or exceeds a predeterminednumber (an alert level). If so, the PC or SCADA system 240 issues analert, logs the alert in the database 290, and notifies the cognizantdepartment of a possible contamination problem in the room/site. The PCor SCADA system 240 also determines if the number of subjects from aroom/site in alert meets or exceeds, or if the number of colonies in thesubject 265 a meets or exceeds, a predetermined number (an alarm level),the predetermined number for the alarm level being greater than thepredetermined number for the alert level. If so, the PC or SCADA system240 issues an alarm, logs the alarm in the database 290, and notifiesthe cognizant department of a possible contamination problem in theroom/site. The alert and alarm levels for each room/site may be set by aquality control department.

In an exemplary embodiment, in the Steps 604 and 610 during air samplingand in the Steps 704 and 710 during incubation, the barcode scanner 370of inline flow control module 250 a or the barcode scanner connected tothe touchpanel 280 also transmits an identification code of the barcodescanner to the base station 230. The identification code of the barcodescanner identifies the location of the barcode scanner and, hence, thelocation of the scan, e.g., where air sampling or incubation may betaking place. In such embodiment, the user 500 need not scan the barcodelocated at the air sampling or incubation site to obtain the locationinformation as it is automatically transmitted by the barcode scanner inthe Steps 604, 610, 704, and 710.

Illustrated in FIG. 8 is a method 800 by which data relating to asubject is scanned and transferred to the PC or SCADA system 240, inaccordance with an exemplary embodiment of the present invention. Themethod 800 comprises two Steps 802 and 804. The Step 802 is a scanningstep corresponding to the Steps 602, 608, 702, and 708 of the methods600 and 700 in which barcodes are scanned using the barcode scannerconnected to the touchpanel 270, the barcode scanner 280, or the barcodescanner 370 and decoded and in which data is entered into the barcodescanner by the user 500. The Step 804 is a data transmission stepcorresponding to the Steps 604, 610, 704, and 710 of the methods 600 and700, in which data is transmitted to the base station 230 and then tothe PC or SCADA system 240 for storage in the database 290. The PC orSCADA system 240 stores the received data in the database 290 and mayalso analyze the data and transmit a response indicating whether thecorrect subject was sampled and/or that the subject is not expired. Theresponse may be displayed on the touchpanel 270, the barcode scanner280, or the digital air flow switch interface 320. The method 800illustrates the scanning and transmission steps of the methods 600 and700 in greater detail.

The method 800 is now described with reference to FIGS. 2 and 5. In theStep 802, a scan in the room/site is initiated, Step 802 a. Afterbeginning the scan, the user 500, using the barcode scanner, scans thebarcode 266 a on the subject 265 a, Step 802 b. The barcode scannerdecodes the information in the barcode 266 a and temporarily stores it.The user 500 may also enter any remarks regarding the scan. The barcodescanner temporarily stores the inputted remarks.

In an exemplary embodiment of the Step 802, after the Step 802 b isperformed, the method 800 skips Step 802 c. In such exemplaryembodiment, the barcode scanner itself is programmed with locationinformation. Thus, barcode(s) for the room/site need not be scanned, andStep 802 c may be skipped. Additionally, in this exemplary embodiment,the barcode scanner or the PC or SCADA system 240 provides the time anddate information, although it is contemplated that the user 500 mayenter the time and date into the barcode scanner. The method 800 mayproceed to a Step 802 d for scanning the barcode for the user 500. It iscontemplated, however, that this step may also be skipped in variationson this exemplary embodiment. If it is performed, the barcode scannerdecodes the information in the barcode 510 and temporarily stores it.

In another exemplary embodiment of the Step 802, after the Step 802 b isperformed, the method proceeds to the Step 802 c. The user 500 scansseparate barcode(s) for the room/site, e.g., clean room ID. The barcodescanner decodes the information in the room/site barcode(s) andtemporarily stores it. Additionally, in this exemplary embodiment, thebarcode scanner or the PC or SCADA system 240 provides the time and dateinformation, although it is contemplated that the user 500 may enter thetime and date into the barcode scanner. The method 800 may proceed to aStep 802 d for scanning the barcode 510 for the user 500. It iscontemplated, however, that this step may also be skipped in variationson this exemplary embodiment. If it is performed, the barcode scannerdecodes the information in the barcode 510 and temporarily stores it.

After all data is inputted and/or scanned in the Step 802, the method800 proceeds to the Step 804. In this step, the barcode scannertransmits all scanned information, inputted information, and anyinputted remarks as a batch to the base station 230, Step 804 a. Thebase station 230 forwards the information and remarks to the PC or SCADAsystem 240. The PC or SCADA system 240 creates a new record in thedatabase 290 for the received data and stores the received data in thenew record.

The PC or SCADA system 240 analyzes the data received during the method800 and provides a response, via an electronic message, to theroom/site, Step 804 b. The response may indicate whether the subject 265a is the correct subject for the room/site and is not expired. Themethod 800 is complete.

Illustrated in FIG. 9 is an exemplary table 900 stored in the database290, in accordance with an exemplary embodiment of the presentinvention. The table 900 comprises a category 910 for date/time data, acategory 920 for location data, a category 930 for identification data,and an optional category 940 for remarks. In the exemplary embodimentillustrated in FIG. 9, the date/time category comprises a date field 910a and a time field 910 b; the category 920 comprises a room ID field 920a and a site ID field 920 b; the category 930 comprises a field 930 afor the ID of the subjects 265 a through 265 d and a field 930 b for theID of the users (e.g., the user 500); and the category 940 comprises afield 940 a for remarks.

The table 900 illustrates exemplary data stored by the PC or SCADAsystem 240 in the database 290 during air sampling and incubationperiods. In the exemplary embodiment of the table 900 illustrated inFIG. 9, each record of the table 800 includes data obtained duringexecution of the method 800 in either of the Step 602 of the method 600or the Step 702 of the method 700. Record 1 was generated duringperformance of the Step 602 in the method 600 of air sampling. The field910 a of Record 1 indicates that an agar plate (subject) was scanned onFeb. 16, 2011. The field 910 b indicates that the time of the scan was10:22 p.m. The fields 920 a and 920 b indicate that the agar plate waslocated in a room 119 and at a site designated as “Bench.” The field 930a indicates that the agar plate had an ID of “SMA 001,” and the field930 b indicates that the person who scanned the agar plate SMA 001 wasTom. Record 2 indicates that the agar plate having an ID of SMA 001 wasscanned at the bench in Room 119 a short time (i.e., after completion ofa sample cycle) after the time indicated in Record 1 by a different techID.

Records 3-5 were generated during performance of the Step 702 in themethod 700 of incubation. For Records 3-5, the field 930 a indicatesthat the agar plate was SMA 001; the field 920 a indicates that the roomhas changed to room 104; and the site within room 104 is “Incubation.”The field 940 a of Record 4 indicates that 2 colonies have been observedin agar plate SMA 001 during incubation, in which case the colonies havereached an alert level and an alert message is to be sent to a cognizantquality control department. The field 940 a of Record 5 indicates that 3colonies have been observed during incubation, in which case thecolonies have reached an alarm level and an alarm message is to be sentto a cognizant quality control department. Thus, Record 5 indicates thatthe air around the Bench site in room 119 included airborne contaminantsaround the times of 10:22 p.m. through 11:25 p.m. on Feb. 16, 2011 in anamount sufficient to trigger an alarm.

The table 900 includes data for three other agar plates: SMA 005, SMA010, and SMA 011. The Records 6-10 pertain to the agar plate SMA 005,which was located in room 119 at site “LFM” during an air collectionperiod (see Field 920 a of Records 6-7) and in room 104 during anincubation period (see Field 920 a of Records 8-10). The field 940 a forRecord 9 indicates that 2 colonies have been observed during incubation,an amount which is deemed safe for the LFM site. The field 940 a forRecord 10 indicates that 5 colonies have been observed duringincubation, in which case the colonies have reached an alert level andan alert message is to be sent to a cognizant quality controldepartment. Thus, Record 10 indicates that the air around the LFM sitein room 119 included airborne contaminants around the times of 10:26p.m. through 11:30 p.m. on Feb. 16, 2011 in an amount sufficient totrigger an alert.

The Records 11-15 pertain to the agar plate SMA 010, which was locatedin room 2120 at site “Fill 1” during an air sampling period (see Field920 a of Records 11-12) and in room 104 during an incubation period (seeField 920 a of Records 13-15). The field 940 a for Record 14 indicatesthat no colonies have been observed during incubation. The field 940 afor Record 15 indicates that 1 colony has been observed duringincubation, in which case the colonies have reached an alert level andan alert message is to be sent to a cognizant quality controldepartment. Thus, Record 15 indicates that the air around the Fill 1site in room 2120 included airborne contaminants around the times of1:00 p.m. through 2:15 p.m. on Feb. 16, 2011 in an amount sufficient totrigger an alert.

Finally, the Records 16-20 pertain to the agar plate SMA 011, which waslocated in room 2120 at site “Fill 2” during an air sampling period (seeField 920 a of Records 16-17) and in room 104 during an incubationperiod (see Field 920 a of Records 18-20). The field 940 a for Records19 and 20 indicates that one colony has been observed during incubation.Thus, Record 20 indicates that the air around the Fill 2 site in room2120 included airborne contaminants around the times of 1:10 p.m.through 1:15 p.m. on Feb. 16, 2011 in an amount not sufficient totrigger and alert or alarm.

It is to be understood that the system 200 and the methods 600 through800 are not limited to use with subjects 265 a through 265 d which areincubated. Thus, although the subjects 265 a through 265 d may includeliquid impingers, such as agar plates, they may also instead use airfilters, glass-plate impactors, cascade impactors, or inertial samplersfor collecting airborne contaminants. Further, it is to be understoodthat the tracking and monitoring of the subjects 265 a through 265 ddescribed herein may be used in an exemplary alternative embodiment ofthe system 200, generally designated in FIG. 10 as 200′, that does notinclude a controller 210, a vacuum pump 220, and a plurality of inlineflow control modules 250 a, 250 b, 250 c, and 250 d. Instead, in thesystem 200′, the subjects 265 a through 265 d collect contaminants viaother methods. The subjects 265 a through 265 d are tracked, monitored,and logged during collection and incubation according to the method 600through 800 using the barcode scanners, the controller 230, the PC orSCADA system 240, and the database 290 in the system 200′ without theair-sampling components of the system 200.

Although the system 200 is described as including a barcode scanner andthe subjects 265 a through 265 d are described as including respectivebarcodes 266 a through 266 d as are the user 500 (barcode 510) and therooms and sites, it is to be understood that the system 200 is notlimited to use with barcodes. Other identification tags andidentification readers are contemplated. In an alternative embodiment,the system 200 includes an RFID reader, rather than barcode readers, andall of the barcodes are replaced by RFID tags. Further, in embodimentsin which the identification tags are barcodes, it is to be understoodthat the barcodes may be linear barcodes (as shown) or 2D (matrix)barcodes.

These and other advantages of the present invention will be apparent tothose skilled in the art from the foregoing specification. Accordingly,it is to be recognized by those skilled in the art that changes ormodifications may be made to the above-described embodiments withoutdeparting from the broad inventive concepts of the invention. It is tobe understood that this invention is not limited to the particularembodiments described herein, but is intended to include all changes andmodifications that are within the scope and spirit of the invention.

1-20. (canceled)
 21. A system for tracking subjects that collectairborne particles, each of the subjects including a subjectidentification tag encoded with identification information identifyingthe each subject, the system comprising: a plurality of air samplingdevices, each configured to draw air over one of the subjects during airsampling; an identification reader configured to scan one of the subjectidentification tags and decode the identification information encodedwithin the scanned subject identification tag; a computer configured toreceive and store the decoded identification information; and acontroller connected to each of the air sampling devices via vacuumlines that separately controls air flow rates at each of the airsampling devices.
 22. The system of claim 21, further comprising: aplurality of inline flow control modules, each inline flow controlmodule corresponding to one of the plurality of air sampling devices,each of the inline flow control modules configured to separately measurethe air flow realized at the corresponding air sampling device, whereinthe controller is connected to each of the air sampling devices via oneof the inline flow control modules.
 23. The system of claim 21, wherein:the subjects are respectively disposed in one or more locations, eachlocation comprising a location identification tag encoded with locationinformation; and the identification reader is further configured to:scan the location identification tag in the location of the subject thatincludes the scanned subject identification tag; and decode the locationinformation encoded within the scanned location identification tag. 24.The system of claim 23, wherein the computer is further configured toreceive and store the decoded location information.
 25. The system ofclaim 24, wherein the computer is further configured to compare thedecoded location information to the decoded identification informationto determine whether the subject that includes the scanned subjectidentification tag is properly located.
 26. The system of claim 25,wherein the computer is further configured to transmit an indication ofwhether the subject that includes the scanned identification tag isproperly located.
 27. The system of claim 25, further comprising: adatabase for storing scanned information received from theidentification reader, wherein the computer is further configured storethe decoded identification information and the decoded locationinformation in a record in the database.
 28. The system of claim 27,wherein the computer stores a time stamp in the record in the database.29. The system of claim 21, wherein the computer is further configuredto receive and store data obtained during the period when each airsampling devices draws air over each subject.
 30. The system of claim29, wherein the data includes the air flow rate at each of the airsampling devices.
 31. A method for tracking subjects that collectairborne particles, each of the subjects including a subjectidentification tag encoded with identification information identifyingthe each subject, the method comprising: providing a plurality of airsampling devices, each configured to draw air over one of the subjectsduring air sampling; providing a controller connected to each of the airsampling devices via vacuum lines; scanning, by an identificationreader, one of the subject identification tags; decoding theidentification information encoded within the scanned subjectidentification tag; storing the decoded identification information;separately controlling, by the controller, air flow rates at each of theair sampling devices; and drawing air over the subject that includes thescanned subject identification tag.
 32. The method of claim 31, furthercomprising: providing a plurality of inline flow control modules, eachinline flow control module corresponding to one of the plurality of airsampling devices, wherein the controller is connected to each of the airsampling devices via one of the inline flow control modules; andseparately measuring, by the inline air flow control modules, the airflow rates at each of the air sampling devices.
 33. The method of claim31, wherein the one or more subjects are respectively disposed in one ormore locations, each location comprising a location identification tagencoded with location information, the method further comprising:scanning, by the identification reader, the location identification tagin the location of the subject that includes the scanned subjectidentification tag; and decoding the location information encoded withinthe scanned location identification tag.
 34. The method of claim 23,further comprising: storing the decoded location information.
 35. Themethod of claim 24, further comprising: comparing the decoded locationinformation to the decoded identification information to determinewhether the subject that includes the scanned subject identification tagis properly located.
 36. The method of claim 25, further comprising:transmitting an indication of whether the subject that includes thescanned subject identification tag is properly located.
 37. The methodof claim 25, further comprising: storing the decoded identificationinformation and the decoded location information in a record in adatabase.
 38. The method of claim 27, further comprising: storing a timestamp in the record in the database.
 39. The method of claim 21, furthercomprising receiving and storing, by the computer, data obtained duringthe period when each air sampling devices draws air over each subject.40. The method of claim 29, wherein the data includes the air flow rateat each of the air sampling devices.